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Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke. “Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news

IschemaView launches Rapid Angio neuroimaging system
Medical imaging dev IschemaView said yesterday that it launched its Rapid Angio neuroimaging system designed for use in the angiography suite. The Menlo Park, Calif.-based company said that it partnered with Siemens (NYSE:SI) to integrate the Rapid software with Siemens’ SyngoDynaCT multiphase system for the newly launched imaging solution. Siemens’ SyngoDyna CT Multiphase is a 3D image acquisition technique which uses multiple rotations of a C-arm system to acquire multi-phasic 3D representation of the brain and its perfusion. “The Rapid Angio module, by combining the best-in-class syngoDynaCT system...
Source: Mass Device - March 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Neurological ischemaview Source Type: news

IschemaView wins expanded FDA nod for Rapid neuroimager
Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy. With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute stroke patients with known occlusions of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure. IschemaView touted its Rapid system as the only imaging platform approved for selecting stroke patients for clot removal. “T...
Source: Mass Device - January 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Neurological Regulatory/Compliance ischemaview Source Type: news

Google joins $21m Series A for Viz.ai
Artificial Intelligence healthcare developer Viz.ai has raised $21 million in a Series A funding round joined by GV, formerly known as Google Ventures. The round was led by Kleiner Perkins, the San Francisco-based company said. In connection with the funding round, Kleiner Perkins general partner Mamoon Hamid will join the company’s board of directors. “We were attracted not only to the technology behind Viz.ai and its impact on patient outcomes, but also its adoption model. Many new health-tech solutions struggle to gain traction because they are an outside-in sale to medical teams, requiring changes to proc...
Source: Mass Device - July 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup vizai Source Type: news

Viz.ai wins FDA nod automated CT perfusion software
Artificial Intelligence healthcare developer Viz.ai said yesterday it won FDA 510(k) clearance for its Viz CTP computed tomography perfusion image processing and analysis software. The San Francisco-based company said that the software compliments its current offerings, which include automated large vessel occlusion stroke identification, stroke triage and LVO notification, patient selection, medical image viewing, transport coordination and HIPAA-compliant communications.. “In stroke, good patient outcomes can come down to a matter of minutes. We are proud to offer hospital systems a comprehensive solution that ca...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Software / IT vizai Source Type: news

FDA updates on Baxter Vascu-Guard patch recall
The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths. The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said. While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have bee...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter Source Type: news

Deaths prompt FDA warning on Baxter ’ s Vascu-Guard patch
The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue. The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said. The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occur...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International Source Type: news

Cheetah Medical inks supply deal with Allina Health
Cheetah Medical said today it inked a supplier contract with non-for-profit healthcare system Allina Health. Through the contract, Minnesota and western Wisconsin based Allina Health will gain access to Cheetah Medical’s hemodynamic monitoring solutions to help guide volume management decisions in septic patients, Cheetah Medical said. “Intravenous fluid requirements vary significantly between patients based on underlying health conditions, and it can be a challenge to determine the right amount of fluid needed to properly maintain organ perfusion and optimize care. The Cheetah Medical technology has demonstra...
Source: Mass Device - July 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Cheetah Medical Source Type: news

ECRI, LSE partner for medical device pricing study
The ECRI Institute said earlier this month it inked a partnership deal with the London School of Economics and Political Science’s LSE Health and Social Care group. The Plymouth Meeting, Penn.-based institute said both groups will collaborate on a project that seeks to examine medical device pricing across different countries. “Reducing costs in the healthcare system is critically important for hospitals and health systems worldwide. We anticipate that our partnership with LSE will yield the kind of research results that are needed to make device pricing more transparent,” ECRI European operations veep Da...
Source: Mass Device - March 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Research & Development ECRI Institute Source Type: news